Licensing of import of drugs in Ukraine (since 2013)
Since the 1st of March 2013 import of drugs in Ukraine will require not only quality certificate issued by a manufacturer but also a license for import of medicines. Prior to the 1st of December 2013 obtainment of such license would require only submission of an application and payment of fee for the license issuance so those who want to obtain one should hurry.
In accordance with “License requirements of conduction of economical activities related to import of drugs” that is approved by the Order of the Ministry of Healthcare of Ukraine number 143 dated 20.02.2013 obtainment of license requires submission of application and documents stipulated in the Resolution of the cabinet of Ministers of Ukraine number 756 dated 04.07.2001. But since amendments that had been made to this resolution and deal with import of drugs will enter into force only on the 1st of December 2013, for the time being those who want to obtain the license can submit only application for license issuance without additional documents. After the 1st of December 2013 it will additionally require copy of importer’s dossier certified by an applicant. The application is filed to the State Administration of Ukraine of Medicinal Drugs.
A decision about issuance of the license is made by the State Administration of Ukraine of Medicinal Drugs on condition that an applicant has appropriate material and technological base, qualified staff and conditions for control over imported medicines. These conditions will be confirmed based on the results of scheduled inspections related to compliance of economical activities with license terms in the field of production of medicines or wholesale of medicines. This also can be done by means of inspection prior to issuance of such licenses. And if such inspections have not been conducted prior to decision about license issuance for import of medicines, the State Administration of Ukraine of Medicinal Drugs will conduct one. Term of such inspection conduction equals to the term which is required to make a decision about issuance of license or denial of such. The term equals to 10 days since the date when an application was received.
Decision about license issuance or about denial of such must be notified (issued to) an applicant in written form within 3 days since the day when such decision was made.
An applicant has to make payment for issuance of the license and provide a document to the State Administration of Ukraine of Medicinal Drugs which confirms the payment within 30 days after he received notification about decision on license issuance. The amount of the payment is 1147 UAH. The license is formalized within 3 business days after filing of document that confirms payment. It is issued along with an annex which includes a list of medicines that are allowed to be imported and special conditions of activities conduction. If a business entity makes a decision to amend the list of medicines he wants to import he will have to replace his annex by applying to the State Administration of Ukraine of Medicinal Drugs.
However obtainment of the license which is quite simple at the moment will not be sufficient. From now on besides license obtainment importers will have to comply with a number of general and special organizational rules. In particular:
- Expiration term of imported medicines must be not less than half of term that was defined by a manufacturer on condition that the manufacturer provided expiration term of less than one year or not less than six months if the manufacturer provided expiration term longer than one year;
- Each supply of medicines batch must be documented in compliance with written procedure approved by a licensee;
Besides the licensee is obligated to:
- Keep manufacturer’s quality certificates (paper copies of copies on electronic storage devices) for batches of medicines that have been sold by him for 5 year term but not less than one year after the end of their expiration date;
- Approved written procedures of internal labeling, quarantine and storage of medicines as well as other materials if required;
- Approve sale protocols that are to be made on electronic storage devices or on paper forms and keep them for each batch of a medicine;
- Appoint a person that is to be responsible for dealing with consumers complaints and deciding on their solutions;
- Approve written procedures that define actions that are to be taken in case of consumer complaint about defects of medical products. Any consumer complaint related to defects of medicines must be protocoled and examined;
- Appoint a person responsible for conduction and coordination of medicines withdrawal from circulation;
- Appoint authorized persons who would be responsible for confirmation of medicine batch quality certificate and permission for its sale.
Inspections of compliance with these and other license requirements are planned to be started by the State Administration of Ukraine of Medicinal Drugs since the 1st of January 2014 a therefore importers of medicines, first of all those who have obtained the license, should not delay with bringing their activities in compliance with these requirements.
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